Shield Therapeutics (LSE:STX) has announced that the U.S. FDA has accepted ACCRUFeR®/FeRACCRU® for Priority Review, aiming to expand its use to adolescents with iron deficiency anemia. Approval is expected in 2026. This follows successful Phase 3 trials and could broaden the treatment’s reach, offering a convenient oral option for adolescents and potentially adults who struggle to swallow capsules.
The company’s outlook is shaped by strong technical performance and market momentum. However, financial challenges, including negative profitability and cash flow constraints, weigh on its overall assessment. Additional concerns stem from valuation metrics, with a negative P/E ratio and no dividend yield affecting investor appeal.
About Shield Therapeutics
Shield Therapeutics plc is a specialty pharmaceutical company at the commercial stage, focused on treating iron deficiency, with or without anemia. Its flagship product, ACCRUFeR®/FeRACCRU® (ferric maltol), is available in the U.S. through a partnership with Viatris and licensed to pharmaceutical companies across Europe, China, and Japan.
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